Systems and methods for removal of intravascular leads

ABSTRACT

Systems and methods for extraction of implanted articles are disclosed. According to aspects illustrated herein, there is provided a system for extraction of an implanted article that includes an elongated member, guide member disposed at a distal section of the elongated member and having a pathway in substantially parallel relationship to the elongated member, through which pathway an implanted article can be accommodated, and a cutting mechanism, situated between the distal section of the elongated member and the guide member, for severing a fibrous adhesion about the implanted article to allow the implanted article to be extracted.

RELATED APPLICATIONS

This application claims priority to and benefits of U.S. ProvisionalApplication No. 61/296,610, filed Jan. 20, 2010, U.S. ProvisionalApplication No. 61/305,824, filed Feb. 18, 2010, U.S. ProvisionalApplication No. 61/314,883, filed Mar. 17, 2010, U.S. ProvisionalApplication No. 61/332,007, filed May 6, 2010, U.S. ProvisionalApplication No. 61/362,070, filed Jul. 7, 2010, U.S. ProvisionalApplication No. 61/368,898, filed Jul. 29, 2010, and U.S. ProvisionalApplication No. 61/420,008, filed Dec. 6, 2010. The entirety of all ofthese applications are hereby incorporated herein by reference for theteachings therein.

TECHNICAL FIELD

The presently disclosed embodiments relate to systems and methods forremoval of implanted articles, and more particularly to systems andmethods for removal of intravascular leads from blood vessels.

BACKGROUND

Implantable pacemakers and automatic implantable defibrillators containintravascular leads that are typically inserted into a blood vessel of apatient, for instance, the internal jugular or subclavian vein. Such alead can be advanced into the heart, where the distal section of thelead can be attached to the endocardial surface. Over time, however, thelead may fracture and become non-functional, so that a new lead may needto be inserted to replace the existing lead. The inoperative lead mayalso need to be removed from the vascular system, overtime, as it mayget infected and may increase likelihood of blood clot formation.Removal of an inoperative lead, however, is oftentimes difficult becausesuch a lead may have become ingrown within the vascular system, wherefibrous adhesions may have formed between the lead and blood vessels.

Inoperative lead, in general, may sometimes be removed by simply pullingthe free end of the lead to separate the lead from fibrous adhesions.However, this may lead to the creation of emboli in the blood stream bydislodging the fibrous adhesions in whole or in part, and may result insevere complication or even death of the patient. Several systems havebeen proposed for removal of inoperative leads. For example, U.S. Pat.No. 4,582,056 to McCorkle, Jr. et al. discloses a system that places alocking stylet inside the lead, enabling the physician to place tractionon the lead. Sheaths of increasing diameter may then be advanced overthe lead and rotated to disrupt the adhesions and allow lead removal.Because most leads have a substantially soft body, when an extractionsheath is advanced, the lead will tend to buckle and bunch up in frontof the distal cutting end of the sheath. The buckling lead can increasethe potential for the extraction sheath to veer out of axial alignmentwith the vein, and cut through the wall of the vein during advancement.This potential of the lead to bunch up and veer out of axial alignmentcan be increased in more recent extraction systems, because the morerecent systems also include laser or radiofrequency cutting energy inaddition to an extraction sheath.

Accordingly, there is a need for improved systems and methods forextraction of implanted articles, that can easily extract intravascularleads without some of the issues noted.

SUMMARY OF THE INVENTION

According to aspects illustrated herein, there is provided a system forextraction of an implanted article that includes an elongated member anda guide member disposed at a distal section of the elongated member. Theguide member, in an embodiment, includes a pathway, in substantiallyparallel relationship to the elongated member, and through which animplanted article can be accommodated. The system can further include acutting mechanism, situated between the distal section of the elongatedmember and the guide member, for severing a fibrous adhesion about theimplanted article to allow the implanted article to be extracted.

According to aspects illustrated herein, there is further provided asystem for extraction of an implanted article that includes a guidemember. The system also includes a pathway defined by the guide memberand configured to accommodate an implanted article therethrough. Thesystem further includes a cutting mechanism positioned adjacent to thepathway, so as to enable the cutting mechanism to sever a fibrousadhesion about the implanted article on a luminal side of the implantedarticle.

According to aspects illustrated herein, there is provided further amethod for extraction of an implanted article. To extract an implantedarticle, a proximal end of the implanted article may be accommodate in apathway defined by a guide member. Next, a cutting mechanism may bepositioned adjacent to the guide member, such that the cutting mechanismis oriented to sever an adhesion about the implanted article on aluminal side of the implanted article. The guide member in combinationwith the cutting mechanism may then be positioned distally of a site ofthe adhesion. Subsequently, the adhesion may be severed by the cuttingmechanism and separated from the implanted article.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1A is a schematic view of an extraction system of the presentdisclosure.

FIG. 1B is a cross sectional view of an elongated member of anextraction system of the present disclosure.

FIGS. 2A-2E illustrate various embodiments of an extraction system ofthe present disclosure with a stationary cutting mechanism.

FIGS. 3A-3B illustrate an embodiment of an extraction system of thepresent disclosure with a translating cutting mechanism.

FIG. 4 illustrates an embodiment of an extraction system of the presentdisclosure having a gripping mechanism disposed within a guide member.

FIG. 5 is a schematic view of an embodiment of a guide member of anextraction system of the present disclosure.

FIGS. 6A-6C illustrate an embodiment of the guide member of FIG. 5.

FIGS. 7A-7B illustrate another embodiment of the guide member of FIG. 5.

FIG. 8 illustrates an embodiment of an actuator suitable for use withembodiments of an extraction system of the present disclosure shown inFIGS. 6A-6D and 7A-7C.

FIG. 9A is a schematic view of an embodiment of a guide member of anextraction system of the present disclosure.

FIG. 9B is a schematic view of another embodiment of an extractionsystem of the present disclosure.

FIG. 9C is a schematic view of yet another embodiment of an extractionsystem of the present disclosure.

FIG. 10 shows an embodiment an extraction system of the presentdisclosure in operation.

FIG. 11 is a top view of an embodiment of a kit for extraction of thepresent disclosure.

FIG. 12 is a top view of another embodiment of a kit for extraction ofthe present disclosure.

DESCRIPTION OF SPECIFIC EMBODIMENTS

An extraction system 100 for removal of an implanted article, such apacemaker lead, is shown generally in FIG. 1A. The extraction system 100includes, in one embodiment, an elongated member 102 having a proximalsection 103, a distal section 104, and a longitudinal axis A extendingthe length of the elongated member 102. The elongated member 102 may bedesigned to navigate along a guide wire, a guide catheter, or both to asite of fibrous adhesion about an implanted article. To that end, themember 102 may be sufficiently rigid axially along its length, whileremaining sufficiently flexible radially from side to side. To providethe elongated member with such characteristic, in an embodiment, theelongated member 102 may be made from a plastic or metallic material ora combination thereof. If desired, the elongated member 102 may be madefrom an inelastic material to provide the elongated member withadditional radial rigidity. In an embodiment, the elongated member 102may also be made from a biocompatible material. The elongated member mayalso include material that can minimize or reduce friction, as theelongated member 102 travels to a site of fibrous adhesion about theimplanted article. To further minimize friction, alternatively oradditionally, the elongated member may be coated with a hydrophiliccoating, such as, for example, polyvinylpyrrolidone, polyurethane,poly(acrylic acid), poly(methacrylic acid), poly(dimeth)acrylamide,PTFE, poly(acrylamide), polyvinybutyrol, poly(hydroxyethylmethacrylate)or combinations thereof. The elongated member 102 may also be coatedwith an anti-thrombogenic coating, such as heparin (or its derivatives),urokinase, or PPack (dextrophenylalanine proline argininechloromethylketone) to prevent thrombosis or any other adverse reactiondue to the introduction of the elongated member 102 into the body of apatient. Other components of the extraction system 100, as will bedescribed below, may also be coated with a hydrophilic coating, aanti-thrombogenic coating, or both.

In an embodiment, the elongated member 102 may include one or more innerlumens 201, 203 for passing materials or instrumentation therethrough,as illustrated in FIG. 1B. The inner lumens 201, 203 may include acoating layer, as described above, to minimize or reduce friction as thematerials or instruments are passed through the lumens. At least onelumen of the elongated member 102 may be dimensioned to accept a guidewire, a guide catheter, or both to enable the elongated member 102 tonavigate to a site of fibrous adhesion about the implanted article.

The extraction system 100 can further include a cutting mechanism 108disposed at the distal section 104 of the elongated article 102 to severa fibrous adhesion around the implanted article. In an embodiment, thecutting mechanism 108 can be disposed between the elongated member 102and a guide member 106, so that the cutting mechanism 108 can sever thefibrous adhesion on the luminal side of the implanted article, i.e., theside of the implanted article opposite to the point of tethering of theimplanted article to tissue, for example, a blood vessel. Severingfibrous adhesions on the luminal side may decrease likelihood that thecutting mechanism 108 may come in contact and cause damage to tissue towhich the implanted article is tethered, such as a blood vessel. Itshould be noted that the term “between” as used throughout thisdisclosure refers to the relative position of the cutting mechanism withrespect to the elongated member and the guide member and is not intendedto designate the specific location of the cutting mechanism, forinstance, that the cutting mechanism is directly underneath the guidemember, with respect to the elongated member. Rather, the term “between”is used to generally describe a spatial position of the elongatedmember, the cutting mechanism and the guide member with respect to oneanother.

To the extent necessary, the cutting mechanism 108 may be designed to beof any size, length, height, thickness, or geometric shape. In anembodiment, the height and/or shape of the cutting mechanism 108, aswell as the relative position of the cutting mechanism 108 and the guidemember 106, may be selected to enable the cutting mechanism 108 to severa fibrous adhesion in a manner sufficiently close to the implantedarticle. In that way, the fibrous adhesion can be easily separated fromthe implanted article, such as, by advancing the guide member 106.Suitable cutting mechanisms include, but are not limited to, a blade,electrocautery, electrical wire, cutting electrode, any other mechanismcapable of severing fibrous tissue. In an embodiment, the extractionsystem 100 may include a blade for mechanical severing of the fibrousadhesion and means, such as electrical wire, for heating the blade, theguide member or both in order to enhance severing and separating thefibrous adhesion from the implanted article.

In some embodiments, the cutting mechanism 108 may be stationary withrespect to the elongated member 102. For example, FIGS. 2A-2E illustratevarious embodiments of the extraction system 100 with a stationarycutting mechanism 108. In some embodiments, the cutting mechanism 108may be shielded by the guide member 106. In particular, the cuttingmechanism 108 may be positioned substantially entirely underneath theguide member 106, as shown in FIGS. 2A, 2B and 2C. In other embodiments,a portion of the cutting mechanism 108 may be positioned distally of theguide member 106, as shown in FIG. 2D. In yet other embodiments, thecutting mechanism 108 may be positioned substantially entirely distal tothe guide member 106 and 2E. In some embodiments, as illustrated in FIG.2C, the extraction system 100 may include multiple cutting mechanisms108 a and 108 b.

In other embodiments, such as shown in FIGS. 3A-3B, the cuttingmechanism 108 may translate with respect to the elongated member 102from a first retracted position, as shown in FIG. 3A, to a secondadvanced position, as shown in FIG. 3B. In an embodiment, the cuttingmechanism 108 may translate substantially along the longitudinal axis Aof the elongated member 102. In one embodiment, the translation of thecutting mechanism 108 may be between about 2 mm and about 10 mm. Inanother embodiment, the translation of the cutting mechanism may beabout 5 mm.

Referring back to FIG. 1A, in some embodiments, the cutting mechanism108 may include a control member 115 attached to a distal end of thecutting mechanism 108, so that the cutting mechanism 108 can betranslated, with respect to the elongated member 102, from a firstretracted position to a second advanced position. To advance and retractthe cutting mechanism 108, an actuator 119 may be provided. The actuator119 may be connected to a proximal end of the control member 115 inorder to actuate the cutting mechanism 108. In an embodiment, as shownin FIG. 1A, the actuator may be positioned at the proximal section 103of the elongated member 102. Of course, it should be understood that theactuator 119 may be positioned anywhere along the elongated member 102or may not be attached to the elongated member 102.

The extraction system 100 can further include a guide member 106positioned at the distal section 104 to the elongated member 102. Theguide member 106 may include, in various embodiments, one or more tubesof various length or, for instance, any other design capable ofaccommodating the implanted article. For example, open or closed loopsor rings, such as illustrated in FIG. 9A, can be used. In anotherembodiment, the guide member 106 may have a length sufficient toaccommodate substantially the entire length of the implanted article. Byproviding the guide member 106 with such a length, the implanted articlemay remain within the guide member 106 following separation of theimplanted article from the surrounding tissue to potentially preventfurther contact between the implanted article and the surroundingtissue, and can aid in the ease of the removal of the implanted articlefrom the body of the patient. It should be appreciated that while theextraction system 100 may be described and illustrated as having asingle guide member 106, the extraction system 100 may include multipleguide members 106. Moreover, although the guide member 106 is describedand illustrated herein as a separate element, it should be appreciatedthat in certain embodiments, one or more inner lumens of the elongatedmember 102 may serve as the guide member 106.

As illustrated in FIG. 1A, the guide member 106 can define a pathway 109through which an implanted article can extend and be accommodated. In anembodiment, the pathway 109 may be substantially parallel to thelongitudinal axis A of the elongated member 102. In another embodiment,the pathway 109 may be configured to position the implanted articlereceived in the pathway 109 substantially parallel to longitudinal axisA of the elongated member 102.

The pathway 109, in an embodiment, can be configured to substantiallysecure the implanted article within the pathway 109. In this way, when afibrous adhesion around the implanted article is severed, the implantedarticle can remain securely within the pathway 109. The pathway 109, inone embodiment, may be of any length, as long as the implanted articlebeing accommodated in the pathway 109 can receive sufficient support.Moreover, the pathway 109 may be sized so that the pathway 109 forms asubstantially snug fit over the implanted article, while still allowingthe guide member 106 to move over and about the implanted article. In anembodiment, the pathway 109 may be provided with any design that mayenable the pathway 109 to securely receive and accommodate an implantedarticle. Accordingly, the design of the pathway 109, may vary dependingon the requirements of a particular procedure, that is, depending on theshape and size (i.e., diameter) of the implanted article to beextracted. It should be noted that the guide member 106 may be providedwith a size and shape that compliment the size and shape of pathway 109.Alternatively, guide member 106 may be of a different size and shape incomparison to pathway 109.

The guide member 106, as shown in FIG. 1A, can also include a leadingedge 111 and a trailing edge 113. In an embodiment, the leading edge 111of the guide member 106 may be configured to separate the severedfibrous adhesion from the implanted article, so the implanted articlecan be freed from the adhesion for subsequent removal. The leading edge111 of the guide member 106, by design, may be able to separate fibrousadhesion from the implanted article by virtue of its size, shape,surface character or combinations thereof. To that end, in anembodiment, the leading edge 111 of the guide member 106 may besharpened and/or tapered to enhance separation of the fibrous adhesionfrom the implanted article. It should be appreciated that any designknown in the art for providing a sharpened and/or tapered edge may beemployed in connection with the leading edge 111 of the guide member106. In an embodiment, the guide member 106, or its leading edge 111,may be heated to further enhance separation of the implanted articleform the fibrous adhesion.

In embodiments where the cutting mechanism 108 may translate withrespect to the elongated member 102, the guide member 106 may include,as illustrated in FIG. 4, a grasping mechanism 401 disposed within thepathway 109 of the guide member 106. The grasping mechanism 401 may beemployed to secure the implanted article in place, as the cuttingmechanism 108 severs a fibrous adhesion around the implanted article.Such securing of the implanted article can decrease the likelihood ofthe cutting mechanism 108 deviating from the fibrous adhesion andinjuring a healthy tissue adjacent to the implanted article. Thegrasping mechanism 401, in one embodiment, may be a balloon, inflatablesleeve or cuff, or any adjustable mechanisms capable of securing theimplanted article within the guide member 106. Additionally oralternatively, the extraction system 100 may include one or more loops403 a, 403 b that may be employed to secure the implanted article inplace. Loops 403 a, 403 b may have an inner diameter that can bereleasably adjusted, when the implanted article extends there-through,to secure the implanted article in place.

Referring now to FIG. 5, there is illustrated another embodiment of theguide member 106. In the embodiment illustrated in FIG. 5, the guidemember 106 includes an attachment section 502, which may allow the guidemember 106 to be attached to the elongated member 102. The attachmentsection 502 may or may not be of a similar length and/or height as theguide member 106. In an embodiment, the attachment section 502 may beconfigured to house the cutting mechanism 108 and may be provided withsufficient spacing to allow the cutting mechanism 108 to translatebetween a first retracted position, in which the cutting mechanism 108may be housed inside the attachment section 502 as shown in FIG. 5, anda second advanced position, in which the cutting mechanism 108 may bepositioned substantially distally of the attachment section 502. Theattachment section 502 may include a leading edge 505 and a trailingedge 507. In an embodiment, a notch 509 may be formed in the leadingedge 505 of the attachment section 502. The presence of the notch 509may allow a fiborus adhesion to be cradled or stabilized thereat as thefibrous adhesion is being severed.

In a non-limiting example of the guide member 108, illustrated in FIGS.6A-6D, the attachment section 502 may define a channel 604 designed todirect the movement of the cutting mechanism 108 along a defined path.In an embodiment, such defined path may be a substantially straight linealong the longitudinal axis A of the elongated member 102. The channel604 may be sized to ensure that in operation the cutting mechanism 108does not deviate from a fibrous adhesion around the implanted articleand cut a healthy tissue adjacent to the implanted article. To furtherrestrain the movement of the cutting mechanism 108 along the definedpath, in an embodiment, as illustrated in FIGS. 7A and 7B, theattachment section 502 may include guide slots 703 between the leadingedge 505 and the trailing edge 507 of the attachment section 502. Theguide slots 703, in one embodiment, may be configured to accept guidepins 705 disposed on each side of the cutting mechanism 108, such thatthe guide slots 703 form a track for the cutting mechanism 108 totranslate between the first retracted position, as shown in FIG. 7A, andthe second advanced position, as shown, in FIG. 7B. In an embodiment,the guide pins 705 and guide slots 703 may be configured so as to enablethe cutting mechanism 108 to translate in a substantially straight linealong the longitudinal axis A of the elongated member 102. In anembodiment, the guide slots 703 may be formed at an angle with respectto the longitudinal axis A of the elongated member 102, so that thecutting mechanism may cut progressively deeper into a fibrous adhesionas the cutting mechanism 108 moves from the first retracted position tothe second advanced position.

As noted above in reference to FIG. 1A, the extraction system 100 mayinclude the control member 115 and the actuator 119 for actuating thecutting mechanism 108. The control member 115 may be a wire, a rod orany other device capable of translating the cutting mechanism 108. Sucha control member 115 may be passed through a cutting mechanism lumen 603as shown in FIG. 6A, inside the elongated member 102, and may beattached to the cutting mechanism 108 for actuating the cuttingmechanism 108 between the first retracted position, as shown in FIG. 6B,and the second advanced position, as shown in FIG. 6C. In anotherembodiment, illustrated in FIGS. 7A-7B, the control member 115 mayextend along an outer surface 707 of the elongated member 102. In suchembodiments, to stabilize the control member 115 in the longitudinaldirection, one or more channels 709, 711 may be provided along the outersurface 707 of the elongated member 102 for passing the control member115 therethrough. The control member 115 may be attached to the cuttingmechanism 108 to actuate the cutting mechanism 108 between the firstretracted position, as shown in FIG. 7A, and the second advancedposition, as shown in FIG. 7B. In an embodiment, the control member 115may be actuated using, for example, a spring loaded plunger 801, asshown in FIG. 8, attached to a distal section 803 of the control member115.

In accordance with another embodiment of the present disclosure, asillustrated in FIG. 9A, a guide member 906 may be attached to theelongated member 102 via a cutting mechanism 908. Accordingly, thedifference between this embodiment and the embodiment shown in FIG. 5 isthat in this embodiment the cutting mechanism also serves as theattachment section of the embodiment of FIG. 5. The guide member 906, asillustrated in FIG. 9A, defines a pathway 909 for accommodating animplanted article, as described above in relation to the guide member106. In such an embodiment, the guide member 906 may be disposed at anupper surface 903 of the cutting mechanism 908 substantially opposite apoint at which the cutting mechanism 908 couples to the elongated member102. In other words, the guide member 906 and the cutting mechanism 908may be positioned radially away from the distal potion 104 of theelongated member 102. As in previously-described embodiments, the guidemember 906 may be placed around the implanted article, so that thecutting mechanism 908 can be allowed to maintain a substantially uniformdistance from a fibrous adhesion around the implanted article. In anembodiment, the cutting mechanism 908 may have a triangular shape.However, it should be understood that the cutting mechanism 908,similarly to the cutting mechanism 108, may be of any shape, so long asit can breach a fibrous adhesion. In various embodiments, the cuttingmechanism 908 and the guide member 906 combination, as shown in FIG. 9,may be stationary or translatable with respect to the elongated member102.

In another embodiment, as illustrated in FIG. 9B, the extraction system100 of the present disclosure may include an inflatable member 911. Thepresence of inflatable member 911 may further aid in positioning thecutting mechanism 108 on the luminal side of the implanted article. Inan embodiment, the inflatable member 109 may be positioned in asubstantially opposing relationship to the guide member 108. Theinflatable member 911 may have any design, such as a balloon, a ring, ora cuff. To operate the inflatable member 911, the extraction system 100may further include an inflation tube 913 in fluid communication to theinflatable member 911 at one end, and a pump 915 at an opposite end. Theinflation tube 933 may be disposed on the inside or outside theelongated member 102.

Yet another embodiment of the extraction system 100 of the presentdisclosure is illustrated in FIG. 9C. In such an embodiment, the cuttinginstrument 108 may be delivered through an inner lumen of the elongatedmember 102 and extend from the elongated member 102 to sever a fibrousadhesion. To be able to pass the cutting mechanism 109 through an innerlumen of the elongated member, the cutting mechanism 108 may be selectedfrom a dissection probe, a dissection needle or a similar dissectionmechanism.

In operation, the extraction system 100 may be utilized to sever afibrous adhesion about an implanted article, such as a pacemaker lead,so as to enable ease of removal of the implanted article. In anembodiment, as illustrated in FIG. 10, a fibrous adhesion 1008 may existbetween an implanted article 1010 and a vessel wall 1003 of a vessel1002, such as a wall of a blood vessel, adhering the implanted article1010 to the vessel wall 1003. To gain access to the vessel 1002 toperform the extraction protocol, in an embodiment, a needle may first beused to provide an opening in the vessel 1002 through which a guide wire1004, a guide catheter 1006 or both may be inserted to define a pathwayfor the elongated member 108 to navigate the site of fibrous adhesion1008. The guide wire 1004, guide catheter 1006 or both may be designedto provide sufficient strength and rigidity to support the elongatedmember.

The elongated member 102 may then be directed over the guide wire, theguide catheter or both to the site of fibrous adhesion 1008. In anembodiment, before, or shortly after, the elongated member 102 entersthe vessel 1002, the implanted article 1010 may be inserted into theguide member 106, 906 to help orient the guide member and to position iton the on the luminal side 1014 of the implanted article 1010, so thatthe fibrous adhesion 1008 about the implanted article 1010 may besevered on the luminal side 1012 of the implanted article 1010, i.e. theside of the fibrous adhesion 1008 opposite the point of tethering of theimplanted article 1010 to the vessel wall 1014. In such an embodiment,the guide member 106 may also support the implanted article 1010 duringthe subsequent removal of the implanted article 1010. The guide member106, 906 may also aid in maintaining a desired distance between thecutting mechanism 108, 908 and the implanted article 1010, as thecutting mechanism 108, 908 severs the fibrous adhesion 1008 surroundingthe implanted article 1010. By doing so, the cutting mechanism 108 canmake a substantially uniform cut in the fibrous adhesion 1008surrounding the implanted article 1010, which may subsequently aid inseparating the implanted article 1010 from the fibrous adhesion 1008.

In the embodiments in which the extraction system 100 includes theinflatable member 911, as illustrated in FIG. 9B, upon insertion of theextraction system 100 into the vessel 1002, the inflatable member 911can be inflated to permit subsequent engagement with the implantedarticle, for example, along a wall 1016 of the vessel 1002 opposite thewall 1014, to which the implanted article 1010 is tethered by thefibrous adhesion 1008. Such a design may further aid in maintaining thecutting mechanism 108 on the luminal side 1012 of the implanted article1010.

During the delivery of the elongated member 102 to the site of fibrousadhesion 1008, the cutting mechanism 108, 908 in one embodiment, canstay in the retracted position. Upon encountering the fibrous adhesion1008, the cutting mechanism 108, 908 may be actuated to the advancedposition, as shown in FIG. 10, to sever the fibrous adhesion 1008surrounding the implanted article 1010 along the luminal side 1012 ofthe implanted article 1010. If necessary, the cutting mechanism 108, 908may be repeatedly moved back and forth between the advanced position andthe retracted position until the fibrous adhesion 1008 is severed.

In embodiments where the guide member 106, 906 includes the graspingmechanism 401, the grasping mechanism 401 may be activated to grasp theimplanted article 1010 and hold the implanted article in place beforeactuating the cutting mechanism 108, 908. Once the implanted article1010 is secured, the cutting mechanism 108 may be used to dissect thefibrous adhesion 1008. Following dissection of the fibrous adhesion1008, the grasping mechanism 401 may be deactivate to release theimplanted article 1010 so that the elongated member 102 can be advancedin the distal direction, if desired.

Once the fibrous adhesion 1008 has been severed along the luminal side,the fibrous adhesion 1008 may be separated from the implanted article1010, thus substantially eliminating a connective bond between theimplanted article 1010 and the blood vessel 1002. In one embodiment, theguide member 106, 906 may be advanced distally across the fibrousadhesion 10008 to substantially separate the fibrous adhesion 1008 fromthe implanted article 1010. In another embodiment, the fibrous adhesion1008 may be separated from the implanted article 1010 by simplymanipulating the implanted article 1010, such as by pulling on theimplanted article 1010, rotating the implanted article 1010, or both. Inyet another embodiment, the fibrous adhesion 1008 may separate from theimplanted article 1010 by virtue of severing the fibrous adhesion 1008,without any further actions.

The elongated member 102 may then be advanced distally to a site ofanother adhesion between the implanted article 1010 and the vessel 1002to sever that adhesion and to substantially eliminate another connectivebond between the implanted article 1010 and the vessel 1002. Thisprocess may be repeated until all connective bonds between the implantedarticle 1010 and the vessel 1002 have been eliminated. It should benoted that some adhesions may be severed or spliced open by the guidemember 106, 906 itself, based on its design, without the help of thecutting mechanism, as the elongated member 102 is being advanced alongthe vessel. Once all connective bonds between the implanted article 1010and the vessel 1002 have been eliminated, the implanted article 1010 canbe removed from the body of the patient.

Referring to FIG. 11, in another aspect, a kit 1101 for extraction of animplanted article is provided. The kit 1101 may include an elongatedmember 102 with a proximal section 103, a distal section 104, and alongitudinal axis therebetween. The elongated member 102 may include oneor more inner lumens configured to accept a guide wire, a guidecatheter, or both, so that the elongated member can be navigated to asite of fibrous adhesion. The kit 1101 may also include a guide member106 to be attached to the elongated member 102 at the distal section 104of the elongated member 102. The guide member 106 may define a pathway109 for receiving an implanted article. In an embodiment, when the guidemember 108 is attached to the elongated member, the pathway 109 mayextend in a substantially parallel relationship to the elongated member.A cutting mechanism 108 to be attached between the elongated member 102and the guide member 106 may also be provided by the kit 1101. In anembodiment, the guide member 106 and the cutting mechanism 108 may beprovided as a single unit. In another embodiment, as illustrated in FIG.11, the guide member 106 and the cutting mechanism 108 may be providedseparately. The cutting mechanism 108 may include a control member 115attached to its distal end, so that, when the cutting mechanism 108 isattached to the elongated member 102, the cutting mechanism 108 can betranslated with respect to the elongated member 102 from a firstretracted position to a second advanced position. In an embodiment, thecutting mechanism 108 may translate substantially along the longitudinalaxis of the elongated member. The control member 115 may be attachableto the elongated member 102 on the inside of the elongated member 102,such as by passing the control member through an inner lumen of theelongated member 102, or on the outside of the elongated member 102,such as by passing the control member through one or more channels (notshown) disposed on the surface of the elongated member. Moreover, thekit 1101 may also include an actuator 801, such as a spring loadedplunger, to be attached to the proximal end of the control member 115for actuating the control member 115 and the cutting mechanism 108. Itshould of course be understood that the kit 1101 may include the guidemember 906 and the cutting mechanism 908 in addition to or instead ofthe guide member 106 and the cutting mechanism 108.

According to further aspects illustrated herein, there may be provided akit 1201 for extraction of an implanted article. In the kit 1201, theremay be provided a guide member 106 defining a pathway 109 configured toaccommodate an implanted article therethrough. The kit 1201 may alsoinclude a cutting mechanism 108 configured to be positioned in relationto the pathway 109 so as to enable the cutting mechanism 108 to sever afibrous adhesion about the implanted article on a luminal side of theimplanted article. In an embodiment, the guide member 106 and thecutting mechanism 108 may be configured for attachment to an elongatedmember. In an embodiment, the guide member 106 and the cutting mechanism108 may be provided as a single unit. In another embodiment, asillustrated in FIG. 12, the guide member 106 and the cutting mechanism108 may be provided separately. The cutting mechanism 108 may include acontrol member 115 attached to its distal end for translating thecutting mechanism 108 from a first retracted position to a secondadvanced position. The kit 1201 may also include an actuator 119 foractuating the control member 115 and the cutting mechanism 108. Itshould be noted again that, similarly to the kit 1011, the kit 1201 mayinclude the guide member 906 and the cutting mechanism 908 in additionto or instead of the guide member 106 and the cutting mechanism 108.

The extraction of the implanted article may, in an embodiment, may bemonitored using an endoscopic technique or any other medical imagingtechnique. In an embodiment, an endoscope may be advanced through theelongated member to be placed in proximity to a fibrous adhesion beingsevered. Other suitable imaging techniques for monitoring extraction ofthe implanted article include, but are not limited to, x-ray,fluoroscopy, magnetic resonance imaging (MRI), ultrasound imaging,Fourier transform infrared spectroscopy, ultraviolet or visiblespectroscopy.

While the invention has been described in connection with the specificembodiments thereof, it will be understood that it is capable of furthermodification. Furthermore, this application is intended to cover anyvariations, uses, or adaptations of the invention, including suchdepartures from the present disclosure as come within known or customarypractice in the art to which the invention pertains, and as fall withinthe scope of the appended claims.

What is claimed is:
 1. An extraction system comprising: an elongatedmember; a guide member disposed at a distal section of the elongatedmember and having a pathway in a substantially parallel relationship tothe elongated member, the pathway having a central axis and beingconfigured to receive an implanted article therethrough, the implantedarticle being attached to a tissue surface by a fibrous adhesion, theguide member being attached to the elongated member by an attachmentsection having guide slots extending between a leading edge and atrailing edge of the attachment section, the guide slots beingconfigured to receive guide pins disposed on each side of the cuttingmechanism; and a cutting mechanism situated entirely between theelongated member and the central axis of the guide member, the cuttingmechanism having a cutting edge being positioned along a portion of thecutting mechanism and spaced apart from the central axis for severingthe fibrous adhesion about the implanted article in a linear manner on aside of the implanted article away from the tissue surface to allow theimplanted article to be extracted.
 2. The system of claim 1, wherein theguide member is configured to maintain the cutting mechanism at asubstantially uniform distance from the implanted article received inthe pathway of the guide member.
 3. The system of claim 1, wherein theguide member comprises a loop attached to an upper surface of thecutting mechanism.
 4. The system of claim 1, wherein the cuttingmechanism extends from the attachment section into the guide member. 5.The system of claim 1, wherein the pathway of the guide member isconfigured to receive an elongated tubular implanted article.
 6. Thesystem of claim 1 wherein the cutting mechanism translates substantiallyalong a longitudinal axis of the elongated member from a first retractedposition to the second advanced position.
 7. The system of claim 1wherein the guide member is configured to maintain the cutting mechanismon a luminal side of the implanted article.
 8. An extraction systemcomprising: an elongated member; a guide member disposed at a distalsection of the elongated member and having a pathway in a substantiallyparallel relationship to the elongated member, the pathway having acentral axis and being configured to receive an implanted articletherethrough, the implanted article being attached to a tissue surfaceby a fibrous adhesion, the guide member being attached to the elongatedmember by an attachment section having guide slots configured to receiveguide pins disposed on each side of the cutting mechanism; and a cuttingmechanism situated entirely between the elongated member and the centralaxis of the guide member, the cutting mechanism having a cutting edgebeing positioned along a portion of the cutting mechanism and spacedapart from the central axis for severing the fibrous adhesion about theimplanted article on a side of the implanted article away from thetissue surface to allow the implanted article to be extracted.
 9. Thesystem of claim 8 wherein the guide member is configured to maintain thecutting mechanism at a substantially uniform distance from the implantedarticle received in the pathway of the guide member.
 10. The system ofclaim 8 wherein the guide member comprises a loop attached to an uppersurface of the cutting mechanism.
 11. The system of claim 8 wherein thecutting mechanism extends from the attachment section into the guidemember.
 12. The system of claim 8 wherein the pathway of the guidemember is configured to receive an elongated tubular implanted article.13. The system of claim 8 wherein the cutting mechanism translatessubstantially along a longitudinal axis of the elongated member from afirst retracted position to the second advanced position.
 14. The systemof claim 8 wherein the guide member is configured to maintain thecutting mechanism on a luminal side of the implanted article.